Phase 3 Clinical Trials:
Four studies of AbbVie’s two drug combination—glecaprevir (protease inhibitor) and pibrentasvir (NS5A inhibitor) were presented.
Endurance 1: 703 genotype 1 non-cirrhotic treatment naïve and treatment experience patients. The patients were treated for 8 or 12 weeks. No ribavirin was used in the study. The cure rates were 99% to 100% across all treatment groups. Endurance 2: 199 genotype 2 non-cirrhotic treatment-naïve and treatment-experience patients treated for 12 weeks achieved 99% to 100%.
Surveyor-II Part 3 Phase 2/3: In genotype 3 patients who were cirrhotic and treatment experienced but who had not been previously treated with a NS5A inhibitor were treated with glecaprevir plus pibrentasvir. Those treated for 12 weeks achieved 91% to 98% cure rates and those treated for 16 weeks achieved 96% cure rates. This treatment was particularly effective for people with end-stage kidney disease.
Surveyor-II Part 4: In genotype 2, 4, 5 or 6 patients without cirrhosis. There were a total of 203 patients—both treatment naïve and treatment experienced (no NS5A treatment experienced). The treatment period was 8 weeks. The cure rates were 98% for genotype 2; 93% for genotype 4; 100% for genotype 5 and 90% for genotype 6—although the number of patients in the genotype 5 and 6 groups were very small.
Expedition-IV: The goal of the study was to treat patients with renal impairment. There were 104 genotype 1 through 6 patients enrolled. The majority of the patients had severe renal impairment, and 82% were on dialysis (filtering of the blood because the kidneys are impaired). The patients were treatment naïve and treatment experienced (no NS5A experienced). The cure rate was 99% (103 of 104)—one patient discontinued treatment before the trial ended.
AbbVie has submitted their study results to the Food and Drug Administration for approval in December.
Alan Franciscus is the Executive Director of the Hepatitis C Support Project and Editor-in-Chief of the HCV Advocate.
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